FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HORIZON 55 BI-CON TORIC
K Number: K950818
·
Decision Mar 21, 1995
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
9
Review Days
26
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Basic Information
- Device Name
- HORIZON 55 BI-CON TORIC
- K Number
- K950818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Westcon Contact Lens Co., Inc.
- Date Received
- February 23, 1995
- Decision Date
- March 21, 1995
- Product Code
- LPL
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Other Clearances by Westcon Contact Lens Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043540 | HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES | Feb 1, 2005 | Substantially Equivalent |
| K031774 | HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES | Feb 20, 2004 | Substantially Equivalent |
| K023530 | HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) | Nov 26, 2002 | Substantially Equivalent |
| K992010 | W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) | Jun 29, 1999 | Substantially Equivalent |
| K963837 | HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN | Dec 20, 1996 | Substantially Equivalent |
| K962121 | HORIZON/WESTHIN 55-G | Aug 26, 1996 | Substantially Equivalent |
| K954524 | W-55 (METHAFILON A) CONTACT LENS | Mar 28, 1996 | Substantially Equivalent |
| K945365 | HORIZON 55 BI-CON | Dec 28, 1994 | Substantially Equivalent |